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Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

Primary Purpose

Major Depressive Disorders

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

amibegron (SR58611A)

placebo

paroxetine

About this trial

This is an interventional treatment trial for Major Depressive Disorders focused on measuring Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

change from baseline of the total score of the HAM-D 17 items.

Secondary Outcome Measures

HAM-D subscores

HAM-D responders and remitters

HAM-A total score and subscores

MADRS total score

clinical global impression (CGI) severity and improvement scores

patient global impression (PGI) improvement score

social and occupational functioning assessment scale (SOFAS) score

clinical monitoring of adverse events (AEs)

laboratory parameters

electrocardiogram (ECG) parameters, change in vital signs and body weight

Full Information

NCT ID

NCT00825058

First Posted

January 16, 2009

Last Updated

March 24, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00825058

Brief Title

Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

Official Title

A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

May 2004 (Actual)

Study Completion Date

October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary objective : To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode. Secondary objectives: To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorders

Keywords

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

317 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

amibegron (SR58611A)

Intervention Description

oral administration 2 X 350mg/day at 12 hours intervals

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral administration 12 hours intervals

Intervention Type

Drug

Intervention Name(s)

paroxetine

Intervention Description

oral 20 mg/day

Primary Outcome Measure Information:

Title

change from baseline of the total score of the HAM-D 17 items.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

HAM-D subscores

Time Frame

6 weeks

Title

HAM-D responders and remitters

Time Frame

6 weeks

Title

HAM-A total score and subscores

Time Frame

6 weeks

Title

MADRS total score

Time Frame

6 weeks

Title

clinical global impression (CGI) severity and improvement scores

Time Frame

6 weeks

Title

patient global impression (PGI) improvement score

Time Frame

6 weeks

Title

social and occupational functioning assessment scale (SOFAS) score

Time Frame

6 weeks

Title

clinical monitoring of adverse events (AEs)

Time Frame

6 weeks

Title

laboratory parameters

Time Frame

6 weeks

Title

electrocardiogram (ECG) parameters, change in vital signs and body weight

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV) patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months. the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name